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Geisinger and Celera to collaborate on liver disease test

DANVILLE, PA and ALAMEDA, CA February 19, 2008 Geisinger Health System and Celera (NYSE:CRA), an Applera Corporation business, today announced that they have entered into a research collaboration with the aim of developing a diagnostic assay for the increased risk of non-alcoholic steatohepatitis (NASH). The collaboration will evaluate Celeras numerous genetic findings in liver diseases, including the Cirrhosis Risk Score, in the Geisinger bank of more than 600 liver tissue and blood case-control samples donated from patients who have undergone bariatric weight loss surgery. The Geisinger biorespository is among the largest of its kind within a research setting. Financial terms of this multi-year collaboration were not disclosed.

Non-alcoholic fatty liver disease (NAFLD) is a condition where there is accumulation of excess fat in the liver. NAFLD is usually asymptomatic and, as a result, many people dont know they have the condition until substantial liver damage has occurred. NASH represents an advanced stage of the disease when the accumulated fat results in significant inflammation and scarring. This occurs in approximately a quarter of the patients and can lead to cirrhosis. Ultimately, a liver transplant may be required. Knowledge of those individuals most likely to suffer from this advanced disease could enable closer monitoring of these individuals, leading to overall improved disease management.

NAFLD is linked to metabolic syndrome characterized by diabetes, obesity, and cardiovascular disease. The American College of Gastroenterology estimates that NAFLD affects 2 to 5 percent of Americans and 10 to 20 percent of those who are obese. Elevated serum aminotransferase levels and evidence of insulin resistance are suggestive of early stages of the disease with ultrasound and liver biopsy used in the diagnosis of the disease.

Even though there are no approved medications for the treatment of NAFLD/ NASH, clinicians strongly encourage patients to lose weight by adopting a low-carbohydrate, low-fat diet and recommend more aggressive control of the often coincident diabetes, dyslipidemia and hypertension, explained Geisinger scientist Glenn S. Gerhard, M.D.

Understanding the natural history of NAFLD and NASH, especially identification of those patients with or at risk for NASH represents a critical unmet diagnostic need in liver disease, said Scott Friedman M.D., Fishberg Professor of Medicine and Chief of Liver Diseases at the Mount Sinai School of Medicine, and a member of the Charles Bronfman Institute for Personalized Medicine. Associations of disease with various gene variants are beginning to provide keen insight into disease mechanisms that may be shared by multiple diseases.

Nonalcoholic fatty liver disease has proven extremely difficult to study, in part because investigators dont have access to well-characterized samples with information on patient outcomes. Multiple sample sets are vital for the replication of genetic association studies, said John Sninsky, Ph.D., Vice President, Discovery Research, at Celera.

"Currently a needle liver biopsy is the only way to definitively diagnose the disease so the development of a blood test to detect NAFLD risk would be a tremendous benefit to patients," said Christopher D. Still, DO, Director of the Center for Nutrition and Weight Management and physician researcher on the project.

Jim Peters, Geisinger Ventures Senior Director and CEO of MedMining, Geisingers data business, noted, Together, Geisinger and Celera bring a synergy of experience and expertise to the table.

According to Geisinger Ventures Director Bryan Allinson, This academic entrepreneurial collaboration will help advance personalized medicine to practical clinical use, which is all part of Abigail Geisingers mission to make patient care The Best.


Contact: Patti Urosevich
Geisinger Health System

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